PER support from a team of IVD experts with inside industry experience.
With a team led by former notified body leadership who contributed to MEDDEV and MDCG guidance documents, RQM+ is uniquely positioned to help you create a strategy for presenting a comprehensive performance evaluation. We know what notified bodies are expecting, and will prepare your team and documentation accordingly.

Every Performance Evaluation Plan that we create balances regulatory, clinical, and business risks and objectives.

    RQM Icon blue 31@2x

With former notified body leaders on staff including Amie Smirthwaite, former Global Head of Clinical Compliance at BSI, and a team of seasoned experts dedicated to PERs, we have unique insights into what notified bodies will accept and creative strategies for how to respond to nonconformities.

Our global team has a unique combination of clinical and regulatory expertise, with a deep understanding of how IVDs work, how performance is measured, and what type of clinical evidence and analysis is required.  

Led by our clinical team project managers, the RQM+ process begins with gaining a thorough understanding of your products, business objectives, and regulatory strategy. With a focus on demonstrating sufficient clinical data, we will help you implement innovative strategies for using existing data along with helping you create a PMPF plan to meet reviewer expectations.

The RQM+ validated process includes development of the PEP, literature search protocols/reports, and compilation of the PER which includes the state of the art analysis, scientific validity report, analytical performance report, and clinical performance report. We have multiple checkpoints with our clients to maintain alignment, as well as an internal review of the documents to provide the highest quality PER. The clinical regulatory strategy is applied throughout the process to ensure the result meets both yours and the notified body's expectations.

Using our performance evidence matrix and a comprehensive approach to gathering data across multiple departments, we will help you clearly identify gaps and weaknesses in data. We will then help you create a plan for the future, including rationales, justifications, and PMPF planning. Our integrated approach provides a complete picture for reviewers so that they can feel confident in approving the product for CE marking.

Seamless integration of PERs, PMS, and risk management is essential for more than just compliance—it will also save you money. Proper integration ensures data flows consistently across multiple procedures and departments. Why waste valuable resource time by having one department reproduce or reformat data to resolve inconsistencies in procedures and templates? RQM+ will ensure efficiency and effectiveness across the business, reducing opportunities for errors and nonconformities.

Learn more about our complete IVDR Clinical Evidence and PMS Solution

Performance evaluation reports and other documentation must be updated regularly to stay compliant. We can take on routine maintenance on a predetermined schedule so you don’t have to worry about missing deadlines or burdening your internal resources who need to be focused on new products.

Delivery Models

RQM+ offers two delivery models to align with your project's needs and ensure optimal outcomes.

RQM Icon blue 73
Full Service
Technical consulting and project management paired with strategic guidance for in-depth PER delivery.
RQM Icon blue 80
A streamlined approach providing a single experienced resource to cost-effectively complete your PER.

As a strategic partner, we add value by balancing regulatory, clinical, and business needs and risks.

IVDR Transition

Demonstration of sufficient clinical evidence is one of the most critical elements to achieving IVDR certification, and it extends beyond your PER to risk management, PMS, PMPF, and labeling. The RQM+ IVDR implementation team creates technical documentation files that convey a cohesive story of clinical evidence across functions and deliverables. 

We have a team of IVD experts dedicated to creating IVDR technical documentation files. Our unrivaled collective knowledge is continuously growing and applied across all of our clients.

Learn more about IVDR Planning & Execution

Expertly Crafted Performance Evaluation Reports

RQM+ is on the leading edge, supporting multiple clients with development of IVDR technical documentation files and PERs since 2020. As 2021 progresses and this number grows, we will also begin to get notified body feedback on early submissions and further refine our processes. The unrivaled collective knowledge at RQM+ will only continue to grow. The feedback our clients have received on CER submissions under MDR is representative of the quality of our work—one reviewer said we produced the best CERs they had ever seen. We get these results because every project lead is an expert with deep knowledge of the expectations of notified bodies and an understanding of what is sufficient to prove safety, performance, and state of the art. We apply the same level of rigor to our PERs.

Clinical Regulatory Maintenance Packages

The work is not done after certification is granted. Our team can update documents and create reports as new data arises—and periodically as required—so that you are always in compliance. Investing in ongoing maintenance also helps streamline updates to risk management and SSPs and the creation of PSURs.

Clinical Regulatory Affairs require specialized expertise, and the RQM+ team has it. Whether you want to supplement your internal team, bring us in for complex new products, or hand over maintenance to us, we are committed to collaborating with you to deliver right-sized solutions.

RQM Icon blue 68

Innovative Approach
We have mastered the science and art of creating clinical documents that tell a compelling story.

RQM Icon blue 71

Clinical Expertise
Our team is filled with clinicians, engineers, and regulatory experts with experience in a large variety of IVD technologies.

RQM Icon blue 70@2x

Industry Experience
The RQM+ team has firsthand knowledge of the expectations of notified body reviewers.

We are passionate about your success. Tell us more about your needs so we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!